Study Evaluating the Efficacy of Niraparib and Dostarlimab (TSR-042) in Recurrent/Metastatic HNSCC

Phase 2

Active, not recruiting

• Conditions: Head and Neck Cancer
• Interventions: Drug: Niraparib; Drug: Dostarlimab

• Registration Number: NCT04313504
• Lead Sponsor: Trisha Wise-Draper

Brief Summary

The purpose of this study is to determine the best overall response of the combination of dostarlimab and niraparib in patients with recurrent and/or metastatic HNSCC patients.

Detailed Description

Recurrent and/or metastatic HNSCC patients will be treated with combination of the PD-1 inhibitor (dostarlimab) and PARPi (niraparib) concurrently and ORR, PFS and OS will be determined.

Study Timeline

• Study First Submitted: 2020-03-16
• Study First Submitted QC: 2020-03-17
• Study First Posted: 2020-03-18
• Study Start: 2020-11-04
• Primary Completion: 2024-06-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-31
• Last Update Posted: 2024-08-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

• Histologically, cytologically, or radiographically confirmed recurrent or metastatic non cutaneous HNSCC for which there are no surgical or radiation curative options.
• ECOG performance status ≤2
• Patients must be able to swallow pills

Exclusion Criteria

• Nasopharyngeal and salivary gland tumors
• Patients who have not recovered from adverse events due to prior anti-cancer therapy with the exception of alopecia
• Prior exposure to both immunotherapy drugs (PD-1, PDL-1, CTLA-4 inhibitors) and PARP inhibitors. Single exposure to either immunotherapy or PARP inhibitors is allowable.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to niraparib or dostarlimab.
• Patients with uncontrolled intercurrent illness.
• Requirement of any use of steroids greater than the equivalent of 10mg prednisone daily is not allowed.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Niraparib & Dostarlimab	Niraparib	Niraparib starting on Day 0. Niraparib will be administered as continuous daily dose, orally 200 or 300 mg. Dostarlimab IV administered via a 30-minute infusion on Day 1 of every 21 day cycle. 500mg for first 4 doses followed by 1000 mg every 6 weeks.
Niraparib & Dostarlimab	Dostarlimab	Niraparib starting on Day 0. Niraparib will be administered as continuous daily dose, orally 200 or 300 mg. Dostarlimab IV administered via a 30-minute infusion on Day 1 of every 21 day cycle. 500mg for first 4 doses followed by 1000 mg every 6 weeks.

Primary Outcome Measures

Name	Time	Method
Overall Response	8 weeks	Measured by assessing best overall response using RECIST 1.1 in subjects in recurrent and/or metastatic HNSCC patients receiving combination of niraparib and dostarlimab.

Secondary Outcome Measures

Name	Time	Method
Rate of all Adverse Events	30 days after completion of treatment	As determined by CTCAE v5.0 in subjects with recurrent and/or metastatic HNSCC receiving combination of niraparib and dostarlimab.
Progression Free Survival	1 and 3 years	Measured using Kaplan Meier Curves from time of treatment start until time of progression
Overall Survival	5 years	Measured using Kaplan Meier Curves from diagnosis until time of death

Trial Locations

Locations (1)

University of Cincinnati Medical Center; 🇺🇸 Cincinnati, Ohio, United States